Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT05923502
Eligibility Criteria:
Inclusion Criteria:
* To participate in the study voluntarily and sign the informed consent (ICF), with good compliance and cooperative visits;
* Patients must be ≥ 18 years of age (Based on the date of signing the informed Consent (ICF));
* Pathologically or Histologically confirmed NHL including but not limited to the following subtypes:
1. Follicular lymphoma (FL);
2. Chronic lymphocytic leukemia/small lymphocytic lymphoma or Richter syndrome (CLL/SLL or RS);
3. Marginal zone lymphoma (MZL);
4. Peripheral T-cell lymphoma (PTCL);
5. Diffuse large B-cell lymphoma (DLBCL).
* Patients who have received at least one systemic chemotherapy and have relapsed at the end of the treatment or progressed during treatment;
* Must have adequate organ function defined by the following laboratory parameters:
1. Bone marrow function: Absolute neutrophil count (ANC) ≥ 0.5 × 10\^9/L, Platelet count (PLT) ≥ 25 × 10\^9/L, blood transfusion can be used before medication;
2. Liver and kidney function: Aspartate transaminase (AST) and alanine aminotransferase (ALT)≤5.0 × ULN;
3. Estimated creatinine clearance value ≥30 milliliters/minute (as determined by the Cockcroft-Gault method).
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
* Patients with infections should be treated first and then considered for enrollment when the infection is under control.
Exclusion Criteria:
* Female subjects who are pregnant or breastfeeding;
* Estimated lifetime is less than 3 months;
* In the investigator's judgment, patients who require but are unable to receive prophylactic treatment for Pneumocystis or herpes simplex virus (HSV) prior to trial drug treatment;
* History or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function;
* Prior history of drug-induced colitis or drug-induced interstitial pneumonia;
* Known hypersensitivity to Duvelisib or its excipients;
* Administration of medications or foods that are strong inhibitors or inducers of CYP3A beginning 2 weeks prior to the first dose of Duvelisib;
* According to the judgement of the researcher, there are concomitant diseases that seriously endanger the safety of patients or affect the completion of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05923502
Study Brief:
Protocol Section:
NCT05923502